Sunday, May 11, 2014

First Call to Action for FDA Proposed Regulations - Consumer Request for an Extension of Comment Period

On Thursday, May 8th, CASAA released the Overview of its Action Plan Regarding Proposed FDA Regulations.  This is the first of several Calls to Action anticipated in CASAA's Action Plan.   (You will recall from the Action Plan that we are not going to publish our suggestions for substantive comments until a few weeks before the deadline, and we urge consumers to wait until then to offer substantive comment.)

FDA, which took more than three years to issue its 241-page Proposed Regulation (and accompanying 81-page regulatory impact analysis), has given us a mere 75 days to comment. While responding in that timeframe is challenging under any circumstances, the FDA has also posed, by our count, 99 requests for information about THR products (this does not include repeat questions or questions specifically pertaining to cigars). Given the length of time FDA has taken to release the proposed regulations, the massive amount of information FDA is requesting, the length of the document itself, and the devastating impact these regulations will have on a product that is estimated to be approximately 99% less hazardous than combustibles, the 75-day comment period is grossly inadequate.


The First Call to Action is for CONSUMERS to request a 105-day extension of the comment period, requesting a total of 180 days to make comments.  We understand that SFATA, AEMSA, and other industry groups will be providing similar guidance for vendors and manufacturers.

We have prepared a suggested letter--which we encourage you to edit to accurately reflect your views and circumstances--along with instructions on how to request the extension. (Please note that submitting this request will not prevent you from later offering a substantive comment, and should not affect your subsequent comment in any way.)


I.  
SUGGESTED LETTER REQUESTING EXTENSION 
YOU SHOULD EDIT AS APPROPRIATE

Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.




II.
INSTRUCTIONS ON HOW TO MAKE THE REQUEST


  1. Create a document with your comment.  You can use the above sample letter as a template and edit to make it your own.
  2. Access the comment form for the deeming regulation (FDA-2014-N-0189-0001):  FDA Comment Form
  3. Click in the Comment field and copy and paste your comment from Step 1 into the box.
  4. Click in the First Name field and type your first name.
  5. Click in the Last Name field and type your last name.
  6. If you wish to allow FDA to contact you, click to check the "I want to provide my contact information" box. Otherwise, leave this box unchecked. When you check this box, fields are displayed for you to enter your ZIP code and email address.
  7. Click to uncheck the box, "I am submitting on behalf of a third party."
  8. Click the arrow next to the "Category" field to display a menu.
  9. Select a category from the menu.  We recommend "Individual Consumer" for individuals wishing to request an extension personally and not on behalf of any business or group.

    NOTE: FDA has traditionally taken the position that "Individual Consumer" comments will not be published on the Regulations.gov website due to privacy concerns.  There has been some criticism of this position, and FDA has indicated that it will be  publishing "Individual Consumer" comments on the website, although it intends to only publish the individual's first name.  Any identifying information you provide in the Comment field will potentially be visible on the website, so we recommend that you NOT include your name, address, phone number, or email address in the Comment field.
  10. Click the Continue button.  After clicking on the Continue button, you will have an opportunity to review your statement and, if you wish, edit it.  (The Edit button is just to the right of the Submit Comment button in the lower right-hand side of the page.)
  11. On the Your Preview page, click to check the box "read and understand the statement above."
  12. Click the Submit Comment button.
  13. After submitting your comment using the comment form, a confirmation page will appear with your Comment Tracking Number. We recommend that you print the page AND email this comment number as directed in Step 14 below.  (You may wish to copy the entire page into an email to yourself, which you can then forward as directed in Step 14 below.  Copying the entire page and emailing it to yourself will ensure that you have a copy of your comment and comment number.)
  14. Please send the comment number to casaa.fdacommentarchive@gmail.com. It is important that CASAA have a count of how many such requests have been made.  (You may, if you wish, include a copy of your comment, but that is not necessary because all we really need is the comment number.)

202 comments:

  1. Thank you. Now, as consumers, vendors & manufacturers, we need UNITY more than ever. #ifyouvapeadvocate #IMPROOF #vapingmilitia @gringochaz

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    1. this is not how you make your self look intelligent using hash tags and pretending it's twitter.

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    2. Indeed. #hashtagshavetheirtimeandplace

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    3. Nice use of hashtags, especially since they are important search terms!

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    4. Dustin should spend more time worrying about issues than hashtags. #wasteofspace

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    5. Its the Dustins' of the world that have us in this situation in the first place...

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    6. Dustin, Capitalization, punctuation, and the correct spelling of "yourself" and "hashtag" are rather effective in making yourself "look intelligent." #clue4u

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    7. This comment has been removed by a blog administrator.

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    8. Quit griping about hashtags and twitter and other b.s. and just fill out the paper. Geez, bunch of brats! We're all on here for a reason!

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    9. Dustin can't help himself he is just a Twitter twitt...

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    10. #wasnumberbeforepound and will always be #tictactoe

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  2. Done and done. Let's get this train going! ECR has answered your call.

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  3. Edited with narrative account of my success in stopping tobacco cigarettes and tapering off a lifetime nicotine addiction.

    Thank you!

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  4. every vapor across the US needs to do this, we must unite as we are the people with so much quote freedom then this extension should be the least of what we can do together

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  5. Done and tracking/comments number sent to you. I will be encouraging everyone to do this. Thanks.

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  6. Done for both my wife and myself.

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  7. Are you not recommending that we also send something similar to our state representatives, stating that we are imploring the FDA to give us more time to research and respond to their 241 page document and that they should be fighting for our rights to have a reasonable time period to respond?

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    1. I'm trusting that CASAA knows exactly what they're doing. They are much more knowledgeable (and smarter) than I am with their many years of experience dealing with all regulatory boards and officials. They've said they will be providing information about contacting elected officials in the future. My guess is they don't want to make this more complicated than it has to be by asking consumers do more than one step at a time. Personally, I will do exactly what they tell me to do when they tell me to do it.

      If you have a Facebook account CASAA has a group to discuss and ask questions about all things related to e-digs and NRT products, bans, etc.

      Perhaps you might like to join the Facebook group? It's helped me to be able to talk with CASAA and others about everything that is going on.

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    2. well you may want to bend over and take everything the government spoon feeds you. the rest of us don't.

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    3. wow colleen...the point of his post (polite and informative) was to say that casaa has a plan with contacting officials...there is a plan to have waves of contact to maximize the effect. instead of spotty streams of e-mails from people here and there they are trying to consolidate to make a bigger impact.

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    5. Colleen, I trust CASAA to point me in the right direction and to utilize my assistance in the best way possible, That does not mean I bend over for anyone including you.

      CASAA has already said we will be writing our reps when the time is right.

      It might help if you read their first blog post again about how we do this and how we will use multiple steps to fight the FDA's deeming regs.

      Above all keep calm, and vape on!
      Angela

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    6. Scott, this is just the first Call to Action in a series. There are more to follow, including contacting Congress. Stay tuned and ready! :)

      Kristin Noll-Marsh
      Vice President
      CASAA

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  8. Done and sharing with as many as possible.

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  9. Thank you for all you do. On all the days of the year Mother's Day is even more meaningful this year We are letting the powers that be know
    how much we value ours and others lives. My receipt for submitting the CTA comment is 1jy-8c1c-346p

    I will share this over and over in as many ways, that are possible to help in our cause.
    Lisa Belle

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  10. I'm not answering for CASAA but I think writing to reps in congress would be good.

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  11. Is this action only for USA citizens?

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  12. This comment has been removed by the author.

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  13. Done 2 both : )

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  14. Done. Comment Tracking Number sent.

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  15. Done. Thank you for helping us all!

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  16. Sent thank you so much for your help

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  17. Done but missed the part of sending conf #...
    closed the page once i was done.

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  18. E-cigs saved my life They've made my marriage possible. Done and Done.

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  19. Done and sent conf. Am shocked they are seeking to regulate batteries and wires. Will they be trying to regulate matches and lighters next? I am so angry!!

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  20. DONE!
    Thanks for making the letter and instructions super easy.
    We're all over this one!
    whoop whoop!

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  21. Done...forwarded it to a couple of other people too.

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  22. I sent one to my state governor, representative and both democratic canadates for the state of PA. So I'll do this as well

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    1. Can you send me that contact info I also live in PA

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  23. Just did.
    total comment so far as of now: 3,391

    We really need to spread the word and increase that number at least 3 fold so it really has an impact.

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  24. Comment Tracking Number: 1jy-8c1v-mn40 I submitted as an individual consumer/healthcare professional

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  25. Done, forwarded and ready to fight.

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  26. Done!
    Will get my husband to do the same tonight. Thank you!

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  27. Done.

    Awaiting further instructions and game plan

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  28. Done and feeling better already, let us know what's next!

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  29. Done, and am sharing with friends and family and employers and social networks and forums and strangers.

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  30. Done and the fda can suck it!!!!!!!

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  31. Done I'm new to the Vape world but glad too already be of help..

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  32. done and posted to G+. will be spreading the word anyway I can.

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  33. Done and done, keep fighting the good fight. When the masses realize how hard you've worked to preserve their right for a smoke free alternative to cigarettes, CASAA will be hailed as national heroes!

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  34. Thank you CASAA. I will be sending my comments in shortly. I also would like to employ this template to not only FDA, but to my state representative, county and city. Well done.

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  35. Done. Vapers unite! CASAA is fighting the good fight. Government hypocrisy knows no ends. Cigarettes are known killers, yet the keep right on marketing those bad boys.

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  36. Comment submitted.

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  37. Submitted and tracking number emailed! Thank you CASAA for helping us come together as a united front!!
    Nini

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  38. I was happy to send in my comment to the FDA. Thank you for all your hard work and helping all of us Vapors keep our right to Vape.

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  39. Done n done. Didn't know whether to put my receipt number in the subject line or where to put it, so I put it in the subject line n the e mail itself.

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  40. Fellow CASAA members, and members of the vaping community who have not yet joined this very important cause. It's time to start getting busy! All of us; repeat, All of Us need to follow through on this first Call to Action. The FDA needs to hear from EVERYONE! Vapin' in So Cal.

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  41. another request done
    roland coldwell

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  42. DONE!!! My thanks to CASAA!

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  43. Done! Emailed CASAA the tracking number

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  44. Done, also emailed the comment number

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  45. DONE ! Track this! >> 1jy-8c23-texh

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  46. Done, tracking number emailed.

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  47. Outstanding: I have done this too! 1jy-8c23-m1ry

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  48. Here is my confirmation number: 1jy-8c24-pkl7
    I'm not a vaper, but my husband has been for 2 years and has gotten nearly all of our smoking friends to switch over. I truly believe this is such a good thing. I hope the FDA is reasonable when they decide to make these regulations.

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  49. done deal and they even gave me a receipt with a tracking number. :)

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  50. Your Comment Tracking Number: 1jy-8c2c-dwbb

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  51. Done and confirmation info is en route to CASAA.

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  52. is this for US citizens? Jerusalem here :)

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  53. done, done, and done.. plus had 10 more submit now, and will keep telling others.

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  54. Done and Done !

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  55. Thanks to fluid vapor smoke free for over two years. Thanks again Rob. L.savoia

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  56. Done. Comment number sent as instructed.

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  57. Done and spreading across my area in Indiana. Confirmation #1jy-8c2i-u6gh.

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  58. Done & email w tracking number sent. Thank you for your continued efforts on behalf of the vaping community!

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  59. Just submitted the recommended comment with my contact info. Will share link to facebook. Thanks CASAA for allowing a central source so that us individual e-cigarette consumers can speak with a unified voice!

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  60. This is worth the time and effort thank CASAA for helping, Suburban Vapor
    is on board I've been telling everyone who'll listen.

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  61. done. comment number sent

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  62. Done! Comment number sent. Keep up the good work.

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  63. Thank you CASAA. Comment Tracking Number: 1jy-8c31-nj4j emailed

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  64. This comment has been removed by the author.

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  65. E cigs have saved my lungs I've been smoking for years and I'm only 18 I quit cigarettes For 3 months now because of e cigs. If e cigs were to be banned I would for a fact go back to smoking. E cigs have helped out alot and I only have 6 mg of nicotine

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  66. Done! Sent comment tracking number as well, and will continue to share!! Thank you CASAA for all that you do for all of us!!! #vapeon

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  67. Completed. Thank you CASAA!!!

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  68. I am sorry for sounding really dumb here, but I know it's not a good idea to just copy and paste the entire letter without customizing it some so that all letters are not exactly the same. What part should I change a little without changing the impact of the letter? Where should I add my story? Sorry, I just don't want to mess this up.

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    1. Well, I'm trying to do my part and ask for help. Cut and paste it is I guess.

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    2. Dana, in the 4th paragraph from the top: "We have prepared a suggested letter--which we encourage you to edit to accurately reflect your views and circumstances..."

      So, yes, we recommend people customize it with their own opinions ad personal story.

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  69. Did if for husband and myself! Thanks CASAA!!

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  70. Done and will forward to others
    CraigW

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  71. Sent mine today. Thanks for the "heads-up".

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  72. Done! Wife will be sending hers tonight.

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  73. Kristin:

    My Comment Tracking Number: 1jy-8c4j-q6xs

    I don't know if you have seen this but it may help. It's a bit long and sometimes dry, but encompasses every aspect of this issue including nicotine, toxicology, air quality, purity, government control.
    Here is a link to a very illuminating report on this subject from Dr. Lynne Dawkins, Experimental Psychologist and Director of the Drugs and Addictive Behaviors Research Group at the University of East London, UK.

    A public lecture on e-cigarettes was delivered by Dr. Dawkins. This lecture gives an introduction to e-cigarettes, what they are and how they work. It then brings the audience up to date with the current research: who uses them, how and why, nicotine content and delivery, safety issues, harm reduction and regulation.

    http://www.uel.ac.uk/ecigarettelecture

    Electronic cigarettes: What we know so far
    University of East London University of East London
    http://www.youtube.com/watch?v=f6KBGH2F63A&sns=em
    Published on Jul 24, 2013

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  74. Done, as a health professional: 1jy-8c5j-hwgb

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  75. I do have one question, and it may have been asked before and I may have missed it, if so I do apologize.
    I was under the impression that we as consumers were permitted one comment to the FDA on this. If we comment that we want an extension, and tell our story, but do not cover what is in the proposed regulations.... will we be able to make a comment later on down the road to cover what is in the regulations? I do not want to use what could be my one and only comment asking for an extension and not being able to cover the proposed regulations.

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    1. Relliks Vape - you are NOT limited to submitting just one comment.

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  76. Done! Your Comment Tracking Number: 1jy-8c6k-eodm

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  77. Done And Done! ;)

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  79. This comment has been removed by the author.

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  80. My name is JuNae I am 37. I have multiple sclerosis. I haven't smoked a cigarette in 2 years, thanks to ecigarettes.. My neurologist is astounded how well I am doing. I smoked for 20 yrs.. She did an MRI of my chest and my lungs are so clean it looks like I have never smoked. If you take control of this stuff. You will be putting my health at risk. I am a student and going through divorce if it wasn't for the ejuice and ecigarettes I would go right back to smoking. Please don't do this my health would be at risk..
    Sincerely, JuNae Jones

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  81. I am 66 years old and smoked cigarettes for over 50 years. Eciggiss have helped me stop smoking and I love it so much. For the first time in my life I can breath and smell the roses in my garden. I Love all the verity that ejuice gives me and non of mine have anything to do with tobacco. I give and the thanks to my grandson for getting into vaping and eciggss. Please so not take it away or charge me mega taxes on it like you did on my ciggaretts,

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  82. E-cigarettes helped me in more ways then one. I smoked traditional cigarettes for over 27 years and about a year I go I purchased my first electronic cigarette. It helped me in more way then you can even imagine. I can finally run around with my kids again without feeling light headed or out of breath. I can go hiking with them and not feel the urge to stop due to the lack of oxygen in my lungs. I am a better person now, at least in my opinion I am. My taste buds are coming back and I can finally enjoy a nice home cooked meal. I can smell the fresh air, flowers, food, and candles in my house. If you's begin to take away electronic cigarettes or try to regulate them, what does that mean for us? We will be stuck going back to real cigarettes risking our lives to the harmful chemicals and other things found in them. I don't know about you but I don't want to see that happen to anyone. We are a united community as vapors and I will do everything in my power to make sure everyone has the equal opportunity I did to quit smoking. Do not take this away from us. There are lives at risk here, and I can say I truly believe electronic cigarettes saved mine. Once again I feel better, breathe better, sleeping better and even smell better. My kids finally have there father to play and run around with. Don't take that from them.

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  83. i am now 8 years smoke free. had tried everything to stop smoking but nothing worked until i tryed e-cigs. my doctor just advised me that after over 17 years of smoking, now my lungs are has of one who never smoked. please dont make a smoker out of me.

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  84. uhhmm, what is this for? No one has said.
    Batteries? Ejuice?
    What the hell is this for and why is it so important?

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    Replies
    1. This is for everything you can possibly buy that has to do with ecigs. So the government doesn't put outrageous taxes or limit the sale of ecigs by only the "big wig" tobacco companies that have the capability of putting harmful substances or a monopoly on ecigs. It's so you can afford to vape in the future, both financially AND physically.

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